This single-center, prospective clinical trial evaluated the combination of camrelizumab (an anti–programmed death-ligand 1 [PD-L1] antibody), apatinib (an anti-angiogenic agent), and chemotherapy as neoadjuvant therapy in patients with stage II to III triple-negative breast cancer (TNBC). A total of 35 patients were enrolled, with 34 completing treatment. The primary endpoint was pathologic complete response (pCR), and secondary endpoints included overall response rate (ORR) and treatment-related adverse events (TRAEs).
The total pCR rate was 67.6%, and the breast pCR rate was 70.6%. PD-L1–positive patients had a higher total pCR rate compared with PD-L1–negative patients (66.7% vs 50.0%). ORR was 94.1% at the end of neoadjuvant treatment.
Common grade 3 to 4 AEs included elevated alanine aminotransferase (38.2%) and aspartate aminotransferase (29.4%) levels. No significant toxicities or treatment-related deaths were observed.
The combination of camrelizumab, apatinib, and chemotherapy demonstrated high clinical efficacy and favorable safety in the neoadjuvant treatment of stage II to III TNBC, particularly in PD-L1–positive patients. These findings warrant further investigation and potential clinical application.
Source: Zhuang C, et al. Camrelizumab plus apatinib and chemotherapy as neoadjuvant therapy for triple negative breast cancer (TNBC): a single-arm, prospective phase II study (MA-BC-II-026). Presented at: 2025 ASCO Annual Meeting. May 30-June 3, 2025; Chicago, IL. Abstract e12623.